Good Clinical Practice (GCP) in Australia

The principles of Good Clinical Practice (GCP) have their origin in the World Medical Association’s Declaration of Helsinki. The Declaration of Helsinki was responsive to the revelations of the Nuremberg trials conducted after World War II, and its drafters sought to ensure that human subjects involved in clinical research would, in future, have their rights, safety and well-being placed above all other considerations in clinical research. The document has been revised several times since it was first published in 1964.

The Declaration of Helsinki was used as a basis for the development of guidance for the conduct of clinical trials by the International Conference on Harmonisation (ICH). Originally developed for commercially sponsored late phase drug trials, this guidance has become known as the GCP guidelines, even though the guidelines apply to clinical research rather than clinical practice. The GCP guidelines detail the requirements for trial documentation, protocol amendments, requirements such as indemnity, reporting lines for adverse events and provision of medical care for trial participants.

Complementing these guidance documents is Australia’s National Statement on Ethical Conduct in Human Research (2007) - Updated March 2014, published by the NHMRC. The National Statement provides guidance on a wide range of ethical issues in human research. It describes the overarching principles of ethical conduct in research, but also provides guidance for specific types of research, specific instructions for the formation and operation of human research ethics committees, advice regarding consideration of multi-centre research and specific issues for HRECs to consider when reviewing a clinical trial proposal.